FDA Approves GSK’s New Hepatitis B Treatment, Offering Hope for Patients to Discontinue Antiviral Therapy

Washington — The U.S. Food and Drug Administration has approved a new treatment for chronic hepatitis B that could help some patients maintain control of the virus without requiring lifelong antiviral medication.

The FDA announced Tuesday that it had approved Hibsago (bepirovirsen), an injectable treatment developed by pharmaceutical company GSK, for certain adults with chronic hepatitis B who do not have cirrhosis.

The medicine is the first FDA-approved antisense oligonucleotide treatment for hepatitis B. It works by targeting the genetic instructions involved in viral activity, reducing the production of proteins associated with the hepatitis B virus.

Unlike conventional antiviral medications, which generally require prolonged use to suppress the virus, the new treatment offers some patients the possibility of maintaining viral control after discontinuing therapy.

“For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,” said Wendy Carter, acting director of the FDA’s Office of Infectious Diseases.

“Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended. This approval represents an important advance for people living with this serious disease,” Carter added.

The treatment is approved for adults without cirrhosis who have received antiviral medication for at least six months and have achieved suppression of hepatitis B virus levels in their blood.

Eligible patients must also have hepatitis B surface antigen levels of 3,000 international units per milliliter or lower, as determined by an FDA-authorized diagnostic test.

The approval was based on results from two clinical trials comparing Hibsago with a placebo.

Participants received injections beneath the skin for up to 24 weeks while continuing their existing antiviral medications. They remained on those medications for at least another 24 weeks after receiving their final Hibsago injection.

Patients who subsequently met specific clinical and laboratory requirements were permitted to discontinue their antiviral treatment.

Across both studies, 24% of patients treated with Hibsago qualified to stop their existing antiviral medications, compared with none of those receiving a placebo.

Among patients who received Hibsago, 19% maintained viral control 24 weeks after discontinuing all hepatitis B treatment, with hepatitis B surface antigen no longer detectable in their blood.

The results suggest that a subset of patients may achieve sustained viral control without continued medication, although most trial participants did not reach that outcome.

Despite its potential benefits, the FDA warned that Hibsago carries significant safety risks requiring careful patient monitoring.

The treatment’s prescribing information includes a boxed warning for serious liver reactions and reduced platelet counts, which can increase the risk of potentially life-threatening bleeding.

Other potential complications include declining kidney function, severe inflammatory reactions such as vasculitis, and problems associated with improper administration.

Patients will need regular blood tests and medical evaluations before and during treatment to monitor for adverse reactions.

Commonly reported side effects included injection-site reactions, fever, fatigue and headaches, in addition to abnormalities detected through laboratory testing.

The FDA also authorized a companion diagnostic test developed by Roche to help physicians identify patients who qualify for the treatment and monitor their response.

Hibsago received Fast Track and Breakthrough Therapy designations, along with Priority Review, reflecting its potential to address an important unmet medical need.

The approval was granted to GSK plc. The FDA did not announce a timeline for commercial availability outside the United States, including in India.

Chronic hepatitis B is a long-term viral infection that affects the liver and can lead to serious complications, including cirrhosis and liver cancer.

Many patients currently depend on antiviral medications for years to keep the infection under control and reduce the likelihood of progressive liver damage.

The disease remains a significant public health concern across Asia, including India, where vaccination, screening, early diagnosis and access to treatment are essential to reducing its impact.

The approval of Hibsago introduces a new treatment option for eligible patients and represents progress toward achieving sustained control of chronic hepatitis B without continuous antiviral therapy. (Source: IANS)